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Alert Number 67

Remicade Warning

Date: December 23, 2004

Among the autoimmune diseases to which CLL patients seem to be susceptible, rheumatoid arthritis and Crohn's disease are right up there. Infliximab (trade name "Remicade") has become an important drug in treating both of these diseases, which is why I thought this warning is important for our patient community. We have discussed Remicade before on Topics — the efficacy of this drug is accompanied by risk of significant immune suppression. In addition to the earlier warnings of reactivation of TB, potential for secondary lymphoma and other adverse effects, this latest warning from the FDA says we now have additional risk factors to consider.

Liver damage, pneumonia, potential risk of hepatitis reactivation are now added to the list. Liver function is measured by ALT and AST, which have been found to be elevated in some patients taking Remicade. The moral of the story: if you are a patient with compromised liver function and/or immune function, think twice about using Remicade. If you have dormant TB or hepatitis, if you have been exposed to these viruses before in your life, make sure you bring this fact to the attention of your prescribing doctor. I am almost willing to bet the same would be true of many of the Herpes viruses as well, shingles is a common and very painful reactivation of chicken pox, a variety of Herpes virus.

I heard this comment the other day: "I have just gone through chemotherapy, big deal what is wrong with a little more immune suppression, how much worse can it get?" I am afraid the answer is that it can always get much worse. Just because we have CLL does not mean our immune systems are beyond any earthly use. Except in very advanced disease or folks who have really been through all the chemo wars, some arms of the immune system are still working, protecting us from a variety of pathogens out there. Taking multiple hits to the immune system means you are that much more vulnerable, both to external pathogens as well as home grown diseases, such as secondary cancers. It is indeed a fine line we must walk, weighing the risk and rewards very carefully with not much room for knee jerk reactions in either direction.

Be well.

Chaya
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Press Report

Medscape 2004. 2004 WebMD Inc.

Dec. 22, 2004 – The U.S. Food and Drug Administration (FDA) and Centocor have warned healthcare professionals via letter regarding risks of hepatotoxicity and pneumonia associated with the use of infliximab (Remicade), according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Infliximab is a therapeutic biological product indicated for the treatment of rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis. The FDA has received 35 postmarketing reports and three clinical trial reports of severe hepatic reactions (including acute liver failure, jaundice, hepatitis, and cholestasis) in patients receiving infliximab. A causal relationship between use of infliximab and these reactions has not been established. Autoimmune hepatitis was diagnosed in some cases.

The severe hepatic reactions occurred between two weeks to more than one year after initiation of infliximab therapy, and in many cases the diagnoses were not preceded by elevated hepatic aminotransferase levels. Some of these cases were fatal or necessitated liver transplantation. The FDA recommends that patients with signs or symptoms of hepatic dysfunction be evaluated for evidence of liver injury. Infliximab should be discontinued if jaundice and/or marked elevations in hepatic enzymes (5 or more times the upper limit of normal) develop, followed by a thorough investigation of the abnormality.

The FDA notes that chronic carriers of the hepatitis B virus should be monitored prior to infliximab therapy initiation and during treatment, because use of immunosuppressive drugs, including infliximab, has been linked to hepatitis B reactivation in this population. In clinical trials of infliximab, mild or moderate elevations of ALT and AST were observed that did not progress to severe hepatic injury. The FDA has also added pneumonia to the existing warning regarding the risk of serious infections associated with use of infliximab. This addition is based on the results of a clinical trial showing that the addition of infliximab to methotrexate significantly increased the incidence of pneumonia at one year compared with methotrexate therapy alone (1.7% vs 0.3%) in patients with rheumatoid arthritis.

More information regarding the use of infliximab may be obtained by contacting Centocor's Medical Affairs Department at 1-800-457-6399. Adverse events related to use of infliximab may also be reported to Centocor at 1-800-457-6399. Alternatively, this information can be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail using form 3500 to 5600 Fishers Lane, Rockville, MD 20852-9787.
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